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Active Surveillance for ER+ Breast Cancer in Older Women

This study, called ACTIVE, is looking at a different way to manage early-stage, estrogen receptor-positive (ER+) breast cancer in women aged 70 and older. Instead of immediate surgery or other treatments, this study uses "active surveillance." This means doctors will closely watch the cancer with regular breast and underarm ultrasounds for 12 months to see if it grows. The goal is to understand if this approach is safe for small breast cancers that are found through screening. You could be eligible if you are a woman aged 70 or older with this type of breast cancer, and have not yet had surgery, chemotherapy, or radiation for it. The main goal is to see how many participants' tumors grow within 12 months.

Study design
This is an observational study with 50 participants, meaning researchers will watch what happens without giving a specific treatment. It is a single-arm study, so all participants will receive the same active surveillance approach.
What's involved
You would undergo serial breast and underarm ultrasounds for 12 months to monitor your tumor.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 12 months, indicating follow-up for at least this duration.

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NCT07262138

Active Surveillance in Older Women With ER+ Breast Cancer

Recruiting
Not specifiedAges 70+Observational
University of Pittsburgh
~50 participants
Updated 2025-12-03 on ClinicalTrials.gov
What's tested:Active Surveillance

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
12 month rate of tumor progression
Measured over 12 months

Conditions

Early Stage Estrogen Receptor (ER) Positive Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Priscilla F McAuliffe, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Neil Carleton, MD, PhD
[email protected]
412-266-1991
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Women aged 70 years or older with a diagnosis of invasive breast cancer who have not undergone surgical resection of the primary invasive tumor and/or axillary lymph nodes, have not undertaken any systemic therapy, and have not received radiation therapy as a treatment for this diagnosis. Patients with invasive cancer that is identified after excisional biopsy for atypia are included.
Tumors must have been identified through mammographic screening.
cT1a or cT1b (≤ 1cm): Nottingham Grade I or II allowed entry.
cT1c (\>1-2cm): only Nottingham Grade I allowed entry.
Breast cancer must be ER positive and HER2 negative according to the definition below, as assessed by local pathology.
ER is considered positive if there are ≥ 60% positive tumor nuclei in the samples.
HER2 negativity is defined per the current ASCO/CAP Clinical Practice Guideline.
Patients with cognitive impairment are eligible provided that a legal surrogate is able to sign informed consent for study participation.
Archival tissue will be submitted for all participants. Tissue must be confirmed available prior to registration.

Exclusion

Prior anti-cancer therapy (e.g., endocrine therapy, chemotherapy, radiation therapy, or investigational therapy) for the current breast cancer diagnosis.
Current breast cancer diagnosis that is deemed a recurrence, at the discretion of the treating investigator.
Multifocal or multicentric disease.
Patients with a history of contralateral DCIS, or ipsilateral or contralateral LCIS are not eligible. Patients with a history of any ipsilateral breast radiation are not eligible.
Diagnosis of inflammatory breast cancer (T4d).
Male breast cancer.
Any concurrent severe and uncontrolled medical condition that, in the treating clinician's opinion, would pose unacceptable safety risks or compromise compliance with the protocol. Such conditions could include: impairment of gastrointestinal tract function or gastrointestinal disease that may significantly alter the absorption of oral medications (uncontrolled Crohn disease or ulcerative colitis, uncontrolled chronic nausea, vomiting diarrhea, malabsorption, or small bowel resection); severe liver impairment (Child-Pugh Class C).

What this trial measures

  • 12 month rate of tumor progression12 months

    Tumor progression is defined based on the following criteria: * For tumors initially staged at cT1a and cT1b, tumor progression is defined as a greater than or equal to 50% increase in the longest diameter of the target lesion, with reference to the longest diameter at the baseline time point (t = 0mo). * For tumors initially staged at cT1c, tumor progression is defined as a greater than or equal to 25% increase in the longest diameter of the target lesion, with reference to the longest diameter at the baseline time point (t = 0mo).